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Korea Post Marketing Surveillance (PMS) Study of Talzenna®

StatusWithdrawn
PhaseNot specified
SponsorPfizer
Started2027-06-01
View on ClinicalTrials.gov ↗
Why the trial stopped
Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request

Amendment history

2026-09-09
Study Identification, Study Status, Oversight, Study Design, Contacts/Locations, References v13
Withdrawn before enrolling
Trial withdrawn: Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety...
Enrollment targetestimated 600→confirmed 0
2025-11-14
Study Status v12
Primary completion date2026-10-31→2028-11-01
Completion date2026-10-31→2028-11-01
Start date2025-12-31→2027-06-01
2025-09-02
3 amendments v9-v11
3 re-verifications since 2025-06-10, no change to tracked fields
2025-05-16
Study Status v8
Primary completion date2026-11-30→2026-10-31
Completion date2026-11-30→2026-10-31
2025-02-12
Study Status v7
Start date2024-12-31→2025-12-31
Show 6 earlier versions
2024-02-21
Study Status v6
Start date2024-06-01→2024-12-31
2023-09-19
Study Status v5
Re-verified, no change to tracked fields
2023-05-30
Study Status v4
Start date2024-05→2024-06-01
2023-01-04
Study Status v3
Start date2022-08-31→2024-05
2022-08-01
Study Status v2
Primary completion date2026-06-30→2026-11-30
Start date2022-07-01→2022-08-31
2021-11-19
Study Status v1
Start date2021-10-01→2022-07-01
2021-07-23
Original filing
Pfizer
431 trials monitored
See 32 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.
Trial Details
NCT Number NCT04982848
Lead Sponsor Pfizer
Conditions Breast Neoplasms
Start Date 2027-06-01
Primary Completion 2028-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-14